What is Ceplene?
Ceplene is a solution for injection that contains the active substance histamine dihydrochloride (0.5 mg / 0.5 ml).
What is Ceplene used for?
Ceplene is used in combination with interleukin-2 (an anticancer medicine) in the maintenance treatment of adult patients with acute myeloid leukemia, a type of cancer that affects white blood cells. The medicine is used during the patients' first 'remission' (a period without symptoms of the disease after the first course of treatment). The efficacy of Ceplene has not been fully demonstrated in patients over 60 years of age.
Because the number of patients with acute myeloid leukemia is low, the disease is considered rare, and Ceplene was designated an 'orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
The medicine can only be obtained with a prescription.
How is Ceplene used?
Ceplene must be administered under the supervision of a physician experienced in the treatment of acute myeloid leukemia. The recommended dose of Ceplene is one 0.5 mg injection under the skin, twice a day, one to three minutes after the interleukin-2 injection. Ceplene and interleukin-2 are given for 10 cycles. The first three cycles consist of three weeks of treatment, followed by a three-week treatment-free period. The next seven cycles consist of three weeks of treatment, followed by a six-week treatment-free period.
The first time Ceplene is given, the patient's blood pressure, heart rate and lung function should be monitored. Depending on the patient's response to treatment and side effects, the treatment may be suspended or the dose adjusted.
Each injection of Ceplene should be given slowly over a period of 5-15 minutes, given at a site other than that of the interleukin-2 injection and preferably in the thigh or abdomen (tummy). Patients can give the "self-injection after receiving specific instructions.
Ceplene should be used with caution in patients with severe kidney problems or moderate to severe liver problems. The use of Ceplene is not recommended in patients under 18 years of age due to the lack of information on the safety and efficacy of the medicine in this age group.
How does Ceplene work?
The active substance in Ceplene, histamine dihydrochloride, is an immunomodulator. This means that it alters the activity of the immune system (the body's natural defenses). Histamine is a naturally occurring substance in the body that participates in many processes. In the treatment of acute myeloid leukemia, it is believed to have a protective action on the cells of the immune system by defending them from damage. This improves the effectiveness of interleukin-2, a drug that stimulates the immune system to attack cancer cells. When Ceplene is given with interleukin-2, it helps the immune system to destroy any leukemia cells left in the body during remission. This can extend the length of time until acute myeloid leukemia returns.
How has Ceplene been studied?
The effects of Ceplene were first tested in experimental models before being studied in humans. Since histamine is a known substance, the company also presented data from the published literature.
The efficacy of Ceplene was tested in a single main study involving 320 adult patients with acute myeloid leukemia in remission after antileukemic treatment. Ceplene was given in combination with interleukin-2 and compared with no treatment. The main measure of efficacy was the length of time until the disease returned or the patient died.
What benefit has Ceplene shown during the studies?
The combination of Ceplene and interleukin-2 was more effective than no treatment in extending the time period until AML return or patient death: in patients in their first complete remission, the mean time without disease increased. from 291 days without treatment to 450 days after treatment with Ceplene and interleukin-2. There was no effect of Ceplene and interleukin-2 in patients in second or subsequent remission.
What is the risk associated with Ceplene?
The most common side effects with Ceplene (seen in more than 1 in 10 patients) are eosinophilia (increased concentration of eosinophils, a type of white blood cell), thrombocytopenia (decreased blood platelets), headache, dizziness, dysgeusia ( bitter or strange taste in the mouth), tachycardia (rapid heartbeat), flushing, hypotension (low blood pressure), cough, dyspnoea (shortness of breath), nausea, dyspepsia (indigestion), diarrhea, rash, arthralgia (pain in the joints), myalgia (muscle pain), pyrexia (fever), chills, fatigue (tiredness), flu-like symptoms, warmth and reactions (redness, bruising, pain and inflammation) at the injection site. For the full list of side effects reported with Ceplene, see the Package Leaflet.
Ceplene must not be used in people who may be hypersensitive (allergic) to histamine dihydrochloride or any of the other ingredients. The medicine must not be used in patients with severe heart problems or in women who are pregnant or breastfeeding. It should also be used in patients who have received a donor bone marrow transplant or are taking steroids (to reduce or prevent inflammation), clonidine (to reduce high blood pressure), or histamine H2 receptor blockers ( for the treatment of stomach ulcer, indigestion or heartburn).
Why has Ceplene been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ceplene's benefits are greater than its risks in the maintenance therapy of adult patients with acute myeloid leukemia when used in combination with interleukin-2. The committee recommended the granting of a marketing authorization for Ceplene.
Ceplene was authorized under 'exceptional circumstances', as it was not possible to obtain complete information on the medicine as it is a rare disease. Each year, the EMEA will review any new information that may become available and, if necessary, this summary will be updated.
What information is still awaited for Ceplene?
The company will conduct other studies to look in more detail at the effectiveness of the combination of Ceplene and interleukin-2 and how this combination works.
Other information about Ceplene:
On 7 October 2008, the European Commission granted EpiCept GmbH a "Marketing Authorization" for Ceplene, valid throughout the European Union.
For the summary of the opinion of the Committee for Orphan Medicinal Products for Ceplene, click here.
For the full version of Ceplene's EPAR, click here.
Last update of this summary: 08-2008.
The information on Ceplene - histamine dihydrochloride published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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